Cleerly vs Iterative Health
Cleerly analyzes coronary CT angiograms and SKOUT, the Iterative Health product, analyzes live colonoscopy video, so each lands in a different department. A cardiac imaging program that wants plaque volume, stenosis and ischemia likelihood from CCTA is Cleerly's buyer. openFDA lists six Cleerly 510(k)s, the latest two decided in July 2026, and CPT Category I code 75577 took effect in January 2026. An endoscopy center or GI group that wants polyp detection during the procedure is SKOUT's buyer. Its six clearances run from K213686 in August 2022 to K253664 in December 2025.
SKOUT's evidence is a sponsor-run randomized trial of 677 standard and 682 CADe colonoscopies. Adenomas per colonoscopy rose from 0.83 to 1.05 (P=.002) while the adenoma detection rate moved from 43.9% to 47.8% (P=.065). Cleerly's accuracy claim against FFRCT, drawn from the CREDENCE trial, is the vendor's own. Cleerly's home page and SKOUT's product page both send buyers to a demo request in place of a price.
Radiology · Reviewed November 2, 2026
Cleerly
by Cleerly
AI-driven CCTA plaque quantification + CAD staging.
Iterative Health
by Iterative Health · founded 2017
Real-time AI polyp detection for colonoscopy with the FDA-cleared SKOUT system, for endoscopists and endoscopy centers.
When to pick each one
Cleerly
- Coronary CT plaque, stenosis and ischemia analysis
- PowerScribe reporting integration
- CPT Category I code 75577 since January 2026
Iterative Health
- Real-time polyp detection on colonoscopy video
- Six FDA 510(k) clearances, August 2022 to December 2025
- Randomized trial raised adenomas per colonoscopy from 0.83 to 1.05
Score
Each row shows points earned of points available under the published rubric.
Cleerly
52of 100
Iterative Health
42of 100
| Dimension | Cleerly | Iterative Health | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 12.7 / 18.2 | 0 / 18.2 | +12.7 |
| RCT / meta-analysis / systematic review | 3.9 / 7.8 | 0 / 7.8 | +3.9 |
| Funding & adoption signal | 6 / 12 | 8.4 / 12 | -2.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Cleerly
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. The homepage offers a demo request. |
Iterative Health
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Demo request only. |
Evidence
Cleerly
FDA decisions
K260588 (opens in new tab)510(k)2026-07-29
Cleerly LABS
K261210 (opens in new tab)510(k)2026-07-29
Cleerly Plaque
K242338 (opens in new tab)510(k)2025-03-07
Cleerly LABS (v2.0)
K231335 (opens in new tab)510(k)2023-09-08
Cleerly ISCHEMIA
K202280 (opens in new tab)510(k)2020-10-02
Cleerly Labs v2.0
Show 1 more
K190868 (opens in new tab)510(k)2019-11-05
Cleerly Labs
Peer-reviewed
2 PubMed records name Cleerly.
Iterative Health
FDA decisions
K253664 (opens in new tab)510(k)2025-12-22
SKOUT system
K251126 (opens in new tab)510(k)2025-05-09
SKOUT system
K241508 (opens in new tab)510(k)2024-07-03
SKOUT system
K240781 (opens in new tab)510(k)2024-04-19
SKOUT system
K230658 (opens in new tab)510(k)2023-04-07
SKOUT system
Show 1 more
K213686 (opens in new tab)510(k)2022-08-12
SKOUT Software
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Cleerly | Iterative Health |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2017 |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
Open the full radiology comparison
Acute-care triage, mammography screening, CCTA plaque analysis, mobile MRI. 30+ FDA-cleared platforms across stroke, oncology, cardiac. Enterprise sales only — we compared what's deployed where.